NL-OMON54410招募中3 期
A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS - Fenhance - GN41851
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Age 18-55 years
- •Expanded Disability Status Scale score (EDSS) of 0.0-5.5 at screening
- •A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria
- •Neurologically stable for at least 30 days prior to randomization and
- •baseline assessments
- •Ability to complete the 9-HPT for each hand in < 240 seconds
- •Ability to perform the timed 25-Foot Walk Test in < 150 seconds
- •For women of childbearing potential: agreement to remain abstinent or use
- •contraception, and agreement to refrain from donating eggs, women must remain
- •abstinent or use contraceptive methods with a failure rate of < 1% per year
- •during the treatment period, for 8 weeks after the final dose of study
- •medication, and until the teriflunomide elimination protocol is completed
- •For men: agreement to remain abstinent or use a condom, and agreement to
- •refrain from donating sperm, with a female partner of childbearing potential or
- •pregnant female partner, men must remain abstinent or use a condom during the
- •treatment phase, for 8 weeks after the final dose of study drug, and until
- •completion of the teriflunomide elimination protocol. Men must also refrain
- •from donating sperm during this same period.
- •See 4.1.1 of the protocol for all inclusion criteria
排除标准
- •A diagnosis of PPMS or non-active SPMS
- •Disease duration of > 10 years from the onset of symptoms and an EDSS score
- •at screening < 2.0
- •Any known or suspected active infection at screening or baseline, or any
- •major episode of infection requiring hospitalization or treatment with IV
- •anti-microbials within 8 weeks prior to and during screening or treatment with
- •oral anti-microbials within 2 weeks prior to and during screening.
- •Onychomycosis is not exclusionary unless it is being treated with systemic
- •History of cancer including hematologic malignancy and solid tumors within 10
- •years of screening.
- •Known presence of other neurological disorders that could interfere with the
- •diagnosis of MS or assessments of efficacy or safety during the study,
- •clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic,
- •endocrine, metabolic or gastrointestinal disease
- •Any concomitant disease that may require chronic treatment with systemic
- •corticosteroids, immunosuppressants during the course of the study.
- •History of alcohol or other drug abuse within 12 months prior to screening
- •Any previous treatment with immunomodulatory or immunosuppressive medication
- •without an appropriate washout period
- •Receipt of a live or live-attenuated vaccine within 6 weeks prior to
- •randomization
- •Female participants who are pregnant or breastfeeding or intending to become
- •pregnant during the study or 8 weeks (with accelerated teriflunomide
- •elimination procedure (ATEP)) after final dose of study drug
- •Male participants intending to father a child during the study or 8 weeks
- •(with ATEP) after final dose of study drug
- •Presence of cirrhosis (Child-Pugh Class C) or Gilbert's Syndrome
研究者
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